.About the job Job Description Summary Founded in 1998, PTC Therapeutics is a global biopharmaceutical company focused on discovery, development and commercialization of innovative treatments that bring benefits to patients suffering from rare diseases.For more than 25 years, PTC have been harnessing its scientific platforms to deliver a number of life-changing therapies to patients that address the underlying cause of multiple rare diseases. PTC has a footprint in more than 50 countries and offices in 20 countries around the world. Director of Regulatory Affairs EU The Director, Regulatory Affairs – EU is responsible for leading strategically and operationally the planning, management, support and execution of regulatory activities for PTC drug products (clinical and commercial) within the European region (including UK). This role includes responsibility for support of EU regional registration and life cycle management regulatory activities. This individual collaborates with the Executive Director, Regulatory Affairs Europe and works closely with the Vice President, International Regulatory Affairs Management. The role is responsible for ensuring that regional regulatory strategies are executed in compliance with current, applicable regulations and standards. He/she manages direct reports. This incumbent works cross-functionally and serves as a liaison between Global Regulatory Affairs team members, other PTC departments, external service providers and contract manufacturers. The Director, Regulatory Affairs – EU ensures for adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. Job Description ESSENTIAL FUNCTIONS In alignment with PTC's global regulatory strategies, leads the development and implementation of regional regulatory strategies for PTC compounds in all stages of clinical and commercial development. Serves as a liaison to regional regulatory Health Authorities including the European Medicines Agency (EMA), the UK MHRA and other national authorities and provides guidance and advice on regulatory and policy developments within the region to PTC's global regulatory team and other key stakeholders. Actively maintains knowledge of regional regulatory requirements (e.G. new regulations, laws, etc.). Defines strategies for, coordinates the execution of, and ensures the proper archival of regulatory submissions including, but not limited to: Clinical Trial Applications (CTAs); Marketing AuthorizationApprovals (MAAs) including those required to maintain approvals (i.E. variations, renewals) and customized dossiers for the registration of drug products in countries within the region. Provides regulatory support for country specific Early Access Programs (EAPs). This may also include the preparation of supportive regulatory documents for these programs
